Revised July 2018
Researchers may gain access to clinical data, genetic analysis data, and DNA from the NIDA Center for Genetics Studies by obtaining formal approval from the Mental and Substance Use Disorders Repositories and Genetics Resources Access Committee, consisting of program staff from the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the National Institute for Mental Health. Please see below for further information on how to access clinical data, and DNA from the NIDA Center for Genetic Studies.
In addition, some of the studies at the NIDA Center for Genetic Studies have been genotyped to produce whole genome association study (GWAS) data. These data are located in dbGaP (https://www.ncbi.nlm.nih.gov/gap). Access requests for (GWAS) data from these studies are to be submitted to the Joint Aging, Alcohol, Mental Health, and Drug Abuse Access Committee (JAAMDAC), a committee different from the Mental and Substance Use Disorders Repositories and Genetics Resources Access Committee.
The following are taken into consideration for data access:
- experience and qualifications of the applicant principal investigator and co-investigators
- adequacy of research environment
- description of the study and proposed analyses
- ethical considerations
- adequacy of the applicant’s funding resources to support the proposed study
- A statement identifying the public health benefits and risks of the proposed research, and a description of how the findings from the proposed research would be used to promote public health.
Access requests should consist of an original and one (1) copy of the following:
- A cover letter containing the name, mailing address, e-mail address, fax number, and telephone number of the applicant principal investigator. This letter should be written on the letterhead of the sponsoring institution at which the research will be conducted.
- The biographical sketches of the applicant principal investigator and all co-investigators. Use the current NIH format (https://grants.nih.gov/grants/forms/biosketch.htm).
- Facilities and Other Resources, using the current NIH format (https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.220-r&r-other-project-information-form.htm#10).
- Funding Information - Including source of funding, period of support, active/pending status.
- One-page description of the study and purpose of access request.
- A completed Distribution Agreement.
- A completed List of Requested DNA Samples and Associated Data (use attached form).
- Human Subjects Approval. Some studies will require IRB approval or exemption. When IRB approval or exemption is required, applicants must document human subject approval by an Institutional Review Board (IRB or human subjects committee) constituted according to the requirements of the Dept. of Health & Human Services Office for Human Research Protections (OHRP). Applicants should note that all data and materials in the repository were stripped of all personal identifiers before they were submitted to the repository, such that no identifying information is associated with the samples. However, applicants should provide documentation of IRB review and either approval of the proposed project or exemption of the proposed project from the need for further IRB review. The IRB approval will not be required at the time the Access Request is submitted. However, neither data nor DNA samples will be released until evidence of IRB approval or exemption has been received.
Please email the Access Request to firstname.lastname@example.org
Secretary, NIDA Genetic Data Access Request
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd., Room 4274
Bethesda, MD 20892-9643
Rockville, Maryland 20852 (for courier/overnight mail service)
Data and DNA samples will not be provided until an original signed copy of the Distribution Agreement is received.
After access certification, an electronic data file, documentation, and pedigree drawings will be sent to the applicant. Please use the attached form to e-mail a list comprised of the NIDA Repository ID number and NIDA subject ID number for each subject for which DNA is requested to the NIDA Center for Genetics Studies Project Officer designated on the form. This list will be forwarded to the NIDA Center for Genetic Studies, which will contact the applicant principal investigator regarding shipping and payment instructions.